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Center for Food Safety and Applied Nutrition Library Address; Technical Amendments

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendments.

SUMMARY:

The Food and Drug Administration (FDA or we) is amending certain regulations to update the location of references cited in our food regulations. We are taking this action to reflect the transfer of those references from our facility in College Park, MD, to our library at our main campus in Silver Spring, MD. We also are updating certain regulations to reflect the current names for specific FDA offices.

DATES:

This rule is effective February 3, 2016.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-2112.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Various regulations pertaining to human food have incorporated materials by reference. In general, the regulations have identified a library at the Center for Food Safety and Applied Nutrition (CFSAN), which was (at the time the regulations were published) located in Washington, DC, or in College Park, MD. We recently consolidated our library holdings at our main campus in Silver Spring, MD. Consequently, we are making technical amendments to our regulations at parts 73, 101, 118, 165, 172, 173, 177, 178, 184, 189, 589, and 700 (21 CFR parts 73, 101, 118, 165, 172, 173, 177, 178, 184, 189, 589, and 700) to state that the materials can be found at the FDA Library in Silver Spring, MD. We also are updating certain regulations to reflect the current names for specific FDA offices. The amendments are as follows:

  • We are revising §§ 73.165, 73.585, 165.110, and 173.300 to update the library address from “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
  • We are revising §§ 101.4, 101.81(c)(2)(ii)(A) introductory text and (B)(1) and (2), 101.83, 165.110, 172.155, 172.785, 172.833, 173.25, 173.45, 173.340, 173.357, 173.370, 177.1350, 177.1360, 177.1390, 177.1520, 177.2600, 178.3297, 184.1063, 184.1148, 184.1150, 184.1250, 184.1387, 184.1420, 184.1444, 184.1866, 189.5, 589.2001, and 700.27 to update the library address from “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
  • We are revising § 101.80 to update the library address from “Center for Food Safety and Applied Nutrition's Library, Harvey W. Wiley Federal Building, 5100 Paint Branch Pkwy., College Park, MD” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
  • We are revising § 101.81(c)(2)(ii)(A)(5) to update the library address from “Center for Food Safety and Applied Nutrition Library, 5100 Paint Branch Pkwy., College Park, MD 20740” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
  • We are revising §§ 118.8 and 165.110 to update the library address from “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD, 301-436-2163” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
  • We are revising § 165.110 to update the library address from “Center for Food Safety and Applied Nutrition's Library, 200 C St. NW., Washington DC” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
  • We are revising §§ 165.110, 172.723, 172.736, 172.804, 172.809, 172.864, 172.886, 173.375, 177.1345, 177.1585, 177.1637, 178.1010, 184.1007, 184.1257, 184.1259, 184.1282, 184.1293, 184.1472, 184.1530, 184.1699, 184.1979, 184.1979a, 184.1979b, and 184.1979c to update the library address from “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
  • We are revising §§ 172.167 and 173.356 to update the library address from “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2163” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
  • We are revising § 172.736 to update the library address from “in the library at the Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740” to “at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
  • We are revising § 172.829 to update the library address from “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., rm. 1C-100, College Park, MD 20740” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
  • We are revising § 173.325 to update the library address from “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740 20204-0001” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
  • We are revising § 184.1311 to update the library address from “Center for Food Safety and Applied Nutrition's library, 5100 Paint Branch Pkwy., College Park, MD 20740” to “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.
  • We are revising § 101.83(c)(2)(ii)(A)(2) and (c)(2)(ii)(B)(2), to remove the words “Office of Nutritional Products, Labeling, and Dietary Supplements, Division of Nutrition Science and Policy,” and in their place add “Office Start Printed Page 5590of Nutrition, Labeling and Dietary Supplements, Nutrition Programs Staff”.
  • We are revising § 118.8 to replace “The FDA” with “FDA”.
  • We are revising § 173.300 to add the words “Office of Food Additive Safety”.
  • We are revising § 173.340 to remove the words “Division of Petition Control” and “(HFS-215)” and in their place adding “Office of Food Additive Safety (HFS-200)”.
  • We are revising § 173.357 to remove the words “Division of Petition Control” and “(HFS-215)” and in their place adding “Office of Food Additive Safety (HFS-200)”.
  • We are updating §§ 177.1520 and 177.1585 to remove the words “Office of Premarket Approval” and in their place adding the “Office of Food Additive Safety”.

Publication of this document constitutes final action of these changes under the Administrative Procedure Act (5 U.S.C. 553). These amendments are merely updating the address of CFSAN references and the names of CFSAN offices. FDA, therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary.

Start List of Subjects

List of Subjects

21 CFR Part 73

  • Color additives
  • Cosmetics
  • Drugs
  • Medical devices

21 CFR Part 101

  • Food labeling
  • Nutrition
  • Reporting and recordkeeping requirements

21 CFR Part 118

  • Egg and egg products
  • Incorporation by reference
  • Recordkeeping requirements
  • Safety

21 CFR Part 165

  • Beverages
  • Bottled water
  • Food grades and standards
  • Incorporation by reference

21 CFR Part 172

  • Food additives
  • Reporting and recordkeeping requirements

21 CFR Part 173

  • Food additives

21 CFR Part 177

  • Food additives
  • Food packaging

21 CFR Part 178

  • Food additives
  • Food packaging

21 CFR Part 184

  • Food additives

21 CFR Part 189

  • Food additives
  • Food packaging

21 CFR Part 589

  • Animal feeds
  • Animal foods
  • Food additives

21 CFR Part 700

  • Cosmetics
  • Packaging and containers
End List of Subjects

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR parts 73, 101, 118, 165, 172, 173, 177, 178, 184, 189, 589, and 700 are amended as follows:

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PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

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1. The authority citation for 21 CFR part 73 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

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[Amended]
Start Amendment Part

2. Amend § 73.165 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

3. Amend § 73.585 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part Start Part

PART 101—FOOD LABELING

End Part Start Amendment Part

4. The authority citation for 21 CFR part 101 continues to read as follows:

End Amendment Part Start Authority

Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.

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[Amended]
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5. Amend § 101.4 in paragraphs (h) introductory text and (h)(2) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” wherever it appears and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

6. Amend § 101.80 in paragraph (c)(2)(iii)(C) by removing “Center for Food Safety and Applied Nutrition's Library, Harvey W. Wiley Federal Building, 5100 Paint Branch Pkwy., College Park, MD” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

7. Amend § 101.81 as follows:

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a. In paragraphs (c)(2)(ii)(A) introductory text and (c)(2)(ii)(B)( 1) and (2) remove “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” wherever it appears and add in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part Start Amendment Part

b. In paragraph (c)(2)(ii)(A)( 5) remove “Center for Food Safety and Applied Nutrition Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and add in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

8. Amend § 101.83 in paragraphs (c)(2)(ii)(A)( 2) and (c)(2)(ii)(B)(2) as follows:

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a. Remove “Office of Nutritional Products, Labeling, and Dietary Supplements, Division of Nutrition Science and Policy” and add in its place “Office of Nutrition, Labeling and Dietary Supplements, Nutrition Programs Staff”.

End Amendment Part Start Amendment Part

b. Remove “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” wherever it appears and add in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part Start Part

PART 118—PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS

End Part Start Amendment Part

9. The authority citation for 21 CFR part 118 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331-334, 342, 371, 381, 393; 42 U.S.C. 243, 264, 271.

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[Amended]
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10. Amend § 118.8 in paragraphs (a) and (b) as follows:

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a. Remove “The FDA” wherever it appears and add in its place “FDA”.

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b. Remove “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD, Start Printed Page 5591301-436-2163” wherever it appears and add in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part Start Part

PART 165—BEVERAGES

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11. The authority citation for 21 CFR part 165 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.

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[Amended]
Start Amendment Part

12. Amend § 165.110 as follows:

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a. In paragraphs (a)(2)(iv) and (vii), (b)(4)(iii)(E)( 7)(iv), and (b)(4)(iii)(I), remove “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” wherever it appears and add in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part Start Amendment Part

b. In paragraphs (b)(2)(ii) and (b)(3) introductory text, remove “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2163” wherever it appears and add in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part Start Amendment Part

c. In paragraph (b)(4)(i)(C) introductory text, remove “Center for Food Safety and Applied Nutrition's Library, 200 C St. NW., Washington DC” and add in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039.”

End Amendment Part Start Amendment Part

d. In paragraphs (b)(4)(iii)(E) introductory text, (b)(4)(iii)(E)( 1)(ii) and (iv), (b)(4)(iii)(E)(11)(i), (b)(4)(iii)(E)(14)(i), and (b)(4)(iii)(F)(20), remove “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” wherever it appears and add in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part Start Amendment Part

e. In paragraph (b)(5)(ii) introductory text, remove “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD” and add in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part Start Part

PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

End Part Start Amendment Part

13. The authority citation for 21 CFR part 172 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

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[Amended]
Start Amendment Part

14. Amend § 172.155 in paragraph (c) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

15. Amend § 172.167 in paragraph (d)(2) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2163” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

16. Amend § 172.723 in paragraph (b)(3) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

17. Amend § 172.736 as follows:

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a. In paragraph (b)(1), remove “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and add in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part Start Amendment Part

b. In paragraph (b)(3), remove “in the library at the Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740” and add in its place “at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

18. Amend § 172.785 in paragraph (b)(1) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
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19. Amend § 172.804 in paragraph (c)(2) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

20. Amend § 172.809 in paragraph (b) introductory text by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

21. Amend § 172.829 in paragraph (b) introductory text by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., Rm. 1C-100, College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

22. Amend § 172.833 in paragraphs (b)(2) and (4) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” wherever it appears and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
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23. Amend § 172.864 in paragraph (a)(3) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
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24. Amend § 172.886 in paragraph (c)(2)(iii) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part Start Part

PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

End Part Start Amendment Part

25. The authority citation for 21 CFR part 173 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 342, 348.

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[Amended]
Start Amendment Part

26. Amend § 173.25 in paragraph (b)(2)(ii)(B) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

27. Amend § 173.45 in paragraph (a) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

28. Amend § 173.300 in paragraph (a)(2) as follows:

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a. Remove “Center for Food Safety and Applied Nutrition (HFS-200)” and add in its place “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition”.

End Amendment Part Start Amendment Part

b. Remove “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD” and add in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

29. Amend § 173.325 in paragraph (h) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740 20204-0001” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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30. Amend § 173.340 in the table in paragraph (a)(4) by revising the entry “ n-Butoxypoly(oxyethylene)-poly(oxypropylene)glycol” to read as follows:

End Amendment Part
Defoaming agents.
* * * * *

(a) * * *

(4) * * *

SubstancesLimitations
n-Butoxypoly(oxyethylene)-poly(oxypropylene)glycolViscosity range, 4,850-5,350 Saybolt Universal Seconds (SUS) at 37.8 °C (100 °F). The viscosity range is determined by the method “Viscosity Determination of n-butoxypoly(oxyethylene)-poly(oxypropylene) glycol” dated April 26, 1995, developed by Union Carbide Corp., P.O. Box 670, Bound Brook, NJ 08805, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the material incorporated by reference are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/​federal_​register/​code_​of_​federal_​regulations/​ibr_​locations.html.
*         *         *         *         *         *         *
* * * * *
[Amended]
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31. Amend § 173.356 in paragraph (a) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2163” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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32. Amend § 173.357 in the table in paragraph (a)(2) by revising the entry “Polyethylenimine reaction product with 1,2-dichloroethane (CAS Reg. No. 68130-97-2)” to read as follows:

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Materials used as fixing agents in the immobilization of enzyme preparations.
* * * * *

(a) * * *

(2) * * *

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SubstancesLimitations
*         *         *         *         *         *         *
Polyethylenimine reaction product with 1,2-dichloroethane (CAS Reg. No. 68130-97-2) is the reaction product of homopolymerization of ethylenimine in aqueous hydrochloric acid at 100 °C and of cross-linking with 1,2-dichloroethane. The finished polymer has an average molecular weight of 50,000 to 70,000 as determined by gel permeation chromatography. The analytical method is entitled “Methodology for Molecular Weight Detection of Polyethylenimine,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, and may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/​federal_​register/​code_​of_​federal_​regulations/​ibr_​locations.htmlMay be used as a fixing material in the immobilization of glucoamylase enzyme preparations from Aspergillus niger for use in the manufacture of beer. May be used as a fixing material in the immobilization of: 1. Glucose isomerase enzyme preparations for use in the manufacture of high fructose corn syrup, in accordance with § 184.1372 of this chapter. 2. Glucoamylase enzyme preparations from Aspergillus niger for use in the manufacture of beer. Residual ethylenimine in the finished polyethylenimine polymer will be less than 1 part per million as determined by gas chromatography-mass spectrometry. The residual ethylenimine is determined by an analytical method entitled “Methodology for Ethylenimine Detection in Polyethylenimine,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Residual 1,2-dichloroethane in the finished polyethylenimine polymer will be less than 1 part per million as determined by gas chromatography. The residual 1,2-dichloroethane is determined by an analytical method entitled, “Methodology for Ethylenedichloride Detection in Polyethylenimine,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/​federal_​register/​code_​of_​federal_​regulations/​ibr_​locations.html.
* * * * *
[Amended]
Start Amendment Part

33. Amend § 173.370 in paragraph (c) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

34. Amend § 173.375 in paragraph (a) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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PART 177—INDIRECT FOOD ADDITIVES: POLYMERS

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35. The authority citation for 21 CFR part 177 continues to read as follows:

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Authority: 21 U.S.C. 321, 342, 348, 379e.

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[Amended]
Start Amendment Part

36. Amend § 177.1345 in paragraph (b)(1) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

37. Amend § 177.1350 in paragraph (b)(2) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

38. Amend § 177.1360 in paragraph (d) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

39. Amend § 177.1390 in paragraph (c)(3)(i)(a)( 1) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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40. Amend § 177.1520 in the table in paragraph (b) by revising the entry “Methyl methacrylate/butyl acrylate-grafted polypropylene copolymer containing methyl methacrylate/butyl acrylate-grafted polypropylene (CAS Reg. No. 121510-09-6)” to read as follows:

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Olefin polymers.
* * * * *

(b) * * *

Start Printed Page 5594
SubstanceLimitations
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Methyl methacrylate/butyl acrylate-grafted polypropylene copolymer containing methyl methacrylate/butyl acrylate-grafted polypropylene (CAS Reg. No. 121510-09-6), methyl methacrylate/butyl acrylate copolymer (CAS Reg. No. 25852-37-3), methyl methacrylate homopolymer (CAS Reg. No. 9011-14-7), and polypropylene (CAS Reg. No. 9003-07-0), resulting from the reaction of a mixture of methyl methacrylate and butyl acrylate with polypropylene. The finished product contains no more than 55 percent by weight of polymer units derived from methyl methacrylate and butyl acrylate as determined by a method entitled, “Determination of the Total Acrylic in PP-MMA/BA Polymers,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/​federal_​register/​code_​of_​federal_​regulations/​ibr_​locations.htmlFor use only at levels not to exceed 6 percent by weight of olefin polymers complying with paragraph (c) of this section, items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers complying with items 3.1a, 3.2a, and 3.2b contain not less than 85 weight-percent of polymer units derived from propylene.
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* * * * *
[Amended]
Start Amendment Part

41. Amend § 177.1585 in paragraph (c)(1)(i) as follows:

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a. Remove “Office of Premarket Approval” and add in its place “Office of Food Additive Safety”.

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b. Remove “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and add in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

42. Amend § 177.1637 in paragraph (b)(2) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

43. Amend § 177.2600 in paragraph (c)(4)(i) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

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44. The authority citation for 21 CFR part 178 continues to read as follows:

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Authority: 21 U.S.C. 321, 342, 348, 379e.

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[Amended]
Start Amendment Part

45. Amend § 178.1010 in paragraph (c)(40) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

46. Amend § 178.3297 in the table in paragraph (e) by revising the entry “High-purity furnace black (CAS Reg. No. 1333-86-4)” to read as follows:

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Colorants for polymers.
* * * * *

(e) * * *

Start Printed Page 5595
SubstancesLimitations
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High-purity furnace black (CAS Reg. No. 1333-86-4) containing total polynuclear aromatic hydrocarbons not to exceed 0.5 parts per million, and benzo[a]pyrene not to exceed 5.0 parts per billion, as determined by a method entitled “Determination of PAH Content of Carbon Black,” dated July 8, 1994, as developed by the Cabot Corp., which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1200, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/​federal_​register/​code_​of_​federal_​regulations/​ibr_​locations.htmlFor use at levels not to exceed 2.5 percent by weight of the polymer.
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Start Part

PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

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47. The authority citation for 21 CFR part 184 continues to read as follows:

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Authority: 21 U.S.C. 321, 342, 348, 371.

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[Amended]
Start Amendment Part

48. Amend § 184.1007 in paragraph (b)(1) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

49. Amend § 184.1063 in paragraphs (b) introductory text and (b)(8) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” wherever it appears and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

50. Amend § 184.1148 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

51. Amend § 184.1150 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

52. Amend § 184.1250 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

53. Amend § 184.1257 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

54. Amend § 184.1259 in paragraph (b)(3) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

55. Amend § 184.1282 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

56. Amend § 184.1293 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039.”

End Amendment Part
[Amended]
Start Amendment Part

57. Amend § 184.1311 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039.”

End Amendment Part
[Amended]
Start Amendment Part

58. Amend § 184.1387 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

59. Amend § 184.1420 in paragraph (b) by removing “Center for Food Safety Start Printed Page 5596and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

60. Amend § 184.1444 in paragraph (b)(3) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

61. Amend § 184.1472 in paragraph (a)(2)(iii) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

62. Amend § 184.1530 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

63. Amend § 184.1699 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

64. Amend § 184.1866 in paragraph (b) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

65. Amend § 184.1979 in paragraphs (b)(1) and (2) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” wherever it appears and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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[Amended]
Start Amendment Part

66. Amend § 184.1979a in paragraphs (b)(1) introductory text and (b)(2) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” wherever it appears and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

67. Amend § 184.1979b in paragraphs (b)(1) introductory text and (b)(2) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” wherever it appears and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part
[Amended]
Start Amendment Part

68. Amend § 184.1979c in paragraphs (b)(1) introductory text and (b)(2) by removing “Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740” wherever it appears and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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PART 189—SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD

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69. The authority citation for 21 CFR part 189 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 342, 348, 371, 381.

End Authority
[Amended]
Start Amendment Part

70. Amend § 189.5 in paragraph (a)(6) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part Start Part

PART 589—SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED

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71. The authority citation for 21 CFR part 589 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 342, 343, 348, 371.

End Authority
[Amended]
Start Amendment Part

72. Amend § 589.2001 in paragraph (b)(1)(vi)(B) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

End Amendment Part Start Part

PART 700—GENERAL

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73. The authority citation for 21 CFR part 700 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 352, 355, 361, 362, 371, 374.

End Authority
[Amended]
Start Amendment Part

74. Amend § 700.27 in paragraph (a)(6) by removing “Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740” and adding in its place “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039”.

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Dated: January 27, 2016.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2016-01787 Filed 2-2-16; 8:45 am]

BILLING CODE 4164-01-P